Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy

NCT ID: NCT06062225

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2026-10-31

Brief Summary

The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.

Detailed Description

In the trial, 180 patients with proximal early gastric cancer will be enrolled and then randomly assigned to one of three groups: Group A (Kamikawa, n = 60), Group B (single-tract jejunal interposition, n = 60), or Group C (SOFY reconstruction, n = 60). The general information, past medical history, laboratory and imaging findings, and surgical procedures of each patient will be recorded. Patients in Group A, Group B and Group C will receive Kamikaze reconstruction, single-tract jejunal interposition reconstruction and SOFY reconstruction respectively after standard proximal gastrectomy and lymph nodes dissection. The primary endpoint will be the incidence of reflux esophagitis, while the incidence of anastomotic leakage, anastomotic stenosis, operative time, and intraoperative blood loss will be secondary endpoints to compare the efficacy of these three reconstruction methods after proximal gastrectomy.

Conditions

Proximal Gastric Adenocarcinoma; Gastrectomy; Anastomosis; Reflux Esophagitis; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Kamikawa reconstruction

Patients will be administered Kamikawa reconstruction after proximal gastrectomy.

Group Type: EXPERIMENTAL

Kamikawa

Intervention Type: PROCEDURE

Kamikawa reconstruction after proximal gastrectomy

STJI reconstruction

Patients will be administered Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy.

Group Type: ACTIVE_COMPARATOR

STJI

Intervention Type: PROCEDURE

Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy

SOFY reconstruction

Patients will be administered SOFY reconstruction after proximal gastrectomy.

Group Type: ACTIVE_COMPARATOR

SOFY

Intervention Type: PROCEDURE

SOFY reconstruction after proximal gastrectomy

Interventions

Kamikawa

Kamikawa reconstruction after proximal gastrectomy

Intervention Type: PROCEDURE

STJI

Single-Tract Jejunal Interposition(STJI) reconstruction after proximal gastrectomy

Intervention Type: PROCEDURE

SOFY

SOFY reconstruction after proximal gastrectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age between 20-75 years old, male or female;
• Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC (15);
• No distant metastasis observed on preoperative chest radiograph, abdominal ultrasound or upper abdominal CT;
• ASA grade 1-3;
• Patients without contraindications to surgery;
• Patients and their families voluntarily signing the informed consent form and participating in the study;

Exclusion Criteria

• Patients diagnosed with primary tumors or distant metastasis;
• Patients whose tumor is located in the greater curvature side of the stomach;
• Patients with coagulation dysfunction which could not be corrected;
• Patients who were diagnosed with viral hepatitis and cirrhosis;
• Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin;
• Patients with organ failure such as heart, lung, liver, brain, kidney failure;
• Patients with ascites or cachexia preoperatively in poor general conditions;
• Patients diagnosed with immunodeficiency, immunosuppression or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, SLE, etc.).
• Patients refusing to sign the informed consent of the study;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changzhi People's Hospital Affiliated to Changzhi Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenqing Hu

Role: STUDY_CHAIR

Changzhi People's Hospital Affiliated to Changzhi Medical College

Central Contacts

Dr.Hu

Role: CONTACT

beibeihejiyy@163.com

+8613509754125

Other Identifiers

2020TD27

Identifier Type: -

Identifier Source: org_study_id